GN Store Nord
ESRS disclosure: ESRS S4 \ DR S4-4 \ Paragraph 32 a
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- Provide a detailed description of the processes your organization employs to identify necessary and appropriate actions in response to actual or potential material negative impacts on consumers and end-users. This should include the methodologies used to assess and manage these impacts, as well as the effectiveness of the actions taken.
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Question Id: S4-4_05
GN develops, manufactures, and markets hearing aids, which are classified as medical devices. Ensuring product safety to manage the material risk related to this is fundamental to our business and we adhere to strict regulatory frameworks and safety standards to effectively manage product safety risks.
GN safety policies ensure that our hearing products meet and exceed safety and quality standards, safeguarding user health and well-being. The policies apply to all hearing aids and associated accessories designed and manufactured by the company, covering all aspects from development to post-market monitoring. The policies do not cover third-party accessories or components not designed or manufactured by GN, nor does it apply to non-medical electronics.
Our safety policies outline measures to identify, assess, and mitigate product safety risks throughout the product life cycle. The policies include details on adherence to medical device standards, quality control protocols, and post-market surveillance activities. Furthermore, policies cover risk management approaches focusing on design safety, usability, and compliance with regulations.
Report Date: 4Q2024Relevance: 80%